Heart Rate Variability and Postoperative Nausea Vomiting

The Effects of Propofol and Sevoflurane on Postoperative Heart Rate Variability and Postoperative Nausea Vomiting

Propofol and sevoflurane have different effects on heart rate variability. It has not yet been reported whether this difference in effect remains at recovery time after anesthesia and the difference is related to postoperative nausea and vomiting has not been studied. The aim of this study is observe whether propofol and sevoflurane have different effects on heart rate variability during recovery and the differences can predict the occurrence of postoperative nausea and vomiting.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

Detailed Description

Different types of anesthetics have different effects on heart rate variability. However It has not yet been reported whether this difference in effect remains at recovery time after anesthesia.

Several studies have been reported that preoperative heart rate variability predicted the occurence of postoperative nausea and vomiting. However, whether the difference in heart rate variability after anesthesia is related to the difference in postoperative nausea and vomiting has not been studied. Therefore, this study aims to observe whether propofol and sevoflurane have differences during recovery period after anesthesia in heart rate variabiliy. In addition, we want to examine that these differences during recovery period in heart rate variability can predict the occurrence of nausea and vomiting within 24 hours after surgery.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

20~50 years old female patients who scheduled breast surgery under general anesthesia

Description

Inclusion Criteria:

• Scheduled breast surgery under general anesthesia

Exclusion Criteria:

• Arrhythmia
• Uncooperative with the measuring heart rate variability
• Diabetes
• Hypertension on medication
• Patients taking psychiatric drugs
• Thyroid disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propofol; General anesthesia using propofol infusion	Drug: Propofol; General anesthesia using propofol infusion; Other Names: Propofol infusion
Sevoflurane; General anesthesia using sevoflurane	Drug: Sevoflurane; General anesthesia using sevoflurane; Other Names: Sevoflurane inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability in recovery room	Postoperative heart rate variability measuring at recovery room Frequency domain result: total power, low frequency power, high frequency power, Low frequency/high frequency power ratio	within 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea vomiting impact scale	Q1. Have you vomited or had dry-retching? 0. No; Once; twice; 3 or more times Q2. Have you experienced a feeling of nausea? If yes, has your feeling of nausea interfered with activities of daily living? 0. not at all; Sometimes; often or most of the time; All of the time Add the numerical responses to questions 1 and 2. (total score 0~6)	48 hours after anesthesia
The incidence of postoperative nausea and vomiting	the time of occurence	48 hours after anesthesia
Patient's satisfaction about postoperative nausea and vomiting	verbal rating scale (0~10), 0=very unsatisfied, 10=very satisfied	48 hours after anesthesia

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: sevoflurane; propofol; heart rate variability; postoperative nausea and vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: AJIRB-MED-OBS-20-293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will provide it upon the reasonable personal request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No